Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.1 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.01 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
1 mg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.374 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.037 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.016 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The PNEC derivation was as follows justified:

PNEC freshwater sediment:

K_(susp-water) = 0.935

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_freshwater sediment

= (K_(susp-water) / RHO_(susp)) * PNEC_water * 1000

= (0.935/1150) * 0.1 * 1000

= 0.08 mg/kg wwt

= 0.374 mg/kg dw

PNEC marine water sediment:

K_(susp-water) = 0.935

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_marine water sediment

= (K_(susp-water) / RHO_(susp)) * PNEC_marine water * 1000

= (0.935/1150) * 0.01 * 1000

= 0.008 mg/kg wwt

= 0.0374 mg/kg dw

PNEC soil:

K_(soil-water) = 0.242

RHO_(soil) = 1700

Conversion factor (wwt -> dwt): 1.13

PNEC_soil

= (K_(soil-water) / RHO_(soil)) * PNEC_freshwater * 1000

= (0.242/1700) * 0.1 * 1000

= 0.014 mg/kg wwt

= 0.016 mg/kg dw

Conclusion on classification

Acute aquatic toxicity:

96 h, LC50 (Danio rerio): >500 mg/L (nominal concentration)

48 h, EC50 (Daphnia magna): >1000 mg/L (nominal concentration)

72 h, ErC50 (Pseudokirchneriella subcapitata): >100 mg/L (nominal concentration)

 

Aquatic chronic toxicity:

72 h, ErC10 (Pseudokirchneriella subcapitata): 54.74 mg/L (nominal concentration)

Biodegradation: not inherently biodegradable: 9 % after 28 days (OECD 302B)

Partition coefficient: log Kow = -1.69 at 20 °C

 

Classification according to CLP

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The test substance was found to be not inherently biodegradable and thus not ready biodegradable under the test conditions. The most sensitive test for the aquatic compartment was the toxicity test to algae. This study revealed a 72h-EC50 of >100 mg/L and the 72h-EC10 of 54.74 mg/L. Based on these results, the substance is neither classified as short-term (acute) aquatic toxicity nor classified as long-term (chronic) aquatic toxicity according to Regulation (EC) No 1272/2008 (CLP) as amended for the tenth time in Commission Regulation (EU) 2017/776.